Analysis & Opinion

ROME (Reuters) - Scientists have criticized an Italian government decree allowing a group of terminally-ill patients to continue using an unproven stem cell treatment, saying such therapies may cause harm and risk exploiting desperate people.

The treatment, created by the privately-owned Stamina Foundation, was banned by Italian medicines regulator AIFA last year after it inspected their laboratories, leading to a series of legal challenges by families of patients.

In early March, Health Minister Renato Balduzzi allowed a terminally ill child to continue using the Stamina treatment after hearing the emotional pleas of her parents.

The Health Ministry then issued an official decree on March 21 allowing 32 patients, mainly children, already using the treatment to continue it.

Scientists from around Europe released a statement on Thursday criticizing the decree, warning that Balduzzi was "riding roughshod over existing European licensing criteria", failing to protect patients from exploitation and ignoring the need for sound evidence that therapies are effective.

"These unproven and ill-prepared stem cell therapies, for which there is no scientific basis, will do nothing for patients and their families except make them poorer," said Charles French-Constant from the University of Edinburgh's Center for Regenerative Medicine.

"DANGEROUS PRECEDENT"

Advocates of the therapy say strict regulations work in favor of big drug companies with their portfolio of blockbuster treatments, reducing the pool of potential competitors. But scientists said Stamina's treatment was unproven and risky.

"There is no rationale for this and no evidence that these procedures are not dangerous for patients," said Professor Michele De Luca of the University of Modena.

"This creates a dangerous precedent," he said, adding that anyone could use media pressure and take advantage of patients' hopes of skirting normal evidence-based procedures.

Stem cells are the body's mother cells and can self-renew or multiply while maintaining the ability to transform into any type of cell.

Stem cell therapy involves introducing new adult stem cells into damaged tissue to treat disease. A number of therapies exist but many remain at the experimental stage.

Several judges presiding over the cases brought by patients' families ruled the Stamina treatment should be available under a law that permits the use of unproven therapies for patients who are dying and have no other options.

Supporters of the therapy have held rallies calling for it to be made available to anyone with an incurable disease. One woman staging a near-naked protest in a Rome square with "yes to life, yes to Stamina" scrawled on her body.

Scientists warned that a complication or death as a result of such an untested therapy could become an obstacle for the advancement of all stem cell therapies.

"This would include some of the more promising therapies that have a strong scientific rationale for working in patients with certain types of disorders such as Parkinson's disease," said Roger Barker, Professor of Clinical Neuroscience at the University of Cambridge.

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